The Creation of A New Drug—from Research and Development to Marketing

Abstract: As the world is waiting for an effective drug fighting against COVID-19, it’s necessary for us to know that the development of a new drug is not that easy, and might take a long time to be fully prepared.

Drug development is the process of bringing a novel drug from “bench to bedside”. It can take 10 to 15 years for a drug to be designed, developed and approved for use in patients. So what process does a new drug need to go through from research and development to marketing? This article will take small molecule drugs as an example to list the entire process of drug development.

1. Pre-clinicalResearch

l Research and development (generally 2-3 years)

The first step is generally laboratory research, looking for new compounds with the potential to treat specific diseases, including:

(1) Discovery and confirmation of drug targets

(2) Screening and synthesis of compounds

(3) Verification and optimization of active compounds

l Preclinical Research (generally 2-4 years)

ADME

The first part of the experiment needs to be carried out at the animal level. The purpose of this step is to determine the effectiveness and safety of the drug. The second part needs to be completed in a workshop that meets Good Manufacturing Practice (GMP) requirements.

2. Investigational New Drug (IND)

The main purpose of the IND is to provide sufficient information to prove that the drug is safe to be tested in humans and to prove that the design of the clinical program for research purposes is reasonable. The IND mainly includes applications for phase I, phase II, and phase III clinical trials. Only after the initial clinical trial IND is approved, Applicants can submit applications for expanding clinical trials.

IND application

3. Clinical research (generally 3-7 years)

“In the traditional sense, the clinical research of new drugs was divided into phase I/II/III, and later phase II was divided into phase IIa and IIb, and then the concept of phase 0 appeared. It was proposed that phase 0/I is an early clinical study, IIa is a mid-term clinical study, and phases IIb and III are advanced clinical studies.” said a scientist at CD Bioparticles, one of the leading companies focusing on drug delivery.

The research objectives at different stages are different:

The purpose of Phase 0 is to preliminarily estimate a study in a limited sample size (usually no more than 20) and a limited time (the treatment period of each patient usually does not exceed a few weeks). This step will answer the questions thatwhether the drug is effective, whether a certain dose is effective, and whether development should continue.

pharmacokinetics and pharmacokinetics test

Phase II is the preliminary judgment of efficacy and safety, so it is generally called the safety & activity study (SA study).

Phase III is a confirmatory clinical study that strictly verifies the effects of drugs. Clinical research is introduced at many conferences, often using this type of research as a template to introduce it under the framework of hypothesis testing.

4. FDA Review for New Drug Marketing Approval

When the phase III of human trials is completed and the required non-clinical trials have ended, a set of information can be issued to apply for the approval of the new drug marketing authorization. The main purpose of new drug application (NDA) is to ensure the safety, effectiveness and quality of the listed drugs.

5. FDA Post-Market Safety Monitoring

In order to bring certain new drugs to the market as soon as possible, the FDA launched an accelerated approval program in 1992. Some new drugs used to treat serious or fatal diseases can obtain accelerated approval from the FDA based on relevant alternative indicators that are effective in clinical studies. The FDA requires that the manufacturers of these pre-approved drugs must complete post-marketing studies to prove their effectiveness after the drugs are on the market. Only in this way can these drugs be fully approved by the FDA.

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